Robin Kramer

Experience

1. Quality Engineer Iii- Post Market Surveillance

   Johnson & Johnson MedTech

   Sep 2013 — Present · West Chester, PA, US

   Implemented and refined a new Post Market Surveillance Process to address changing regulatory requirements such as the MDR, a corporate warning letter and TUV compliance deficiencies. Accomplishments include:Implementing the new PSUR process as required by the MDR. Created Post Market Surveillance data for inclusion. Harmonizng and optimizing process between divisions for scoping harm analysis, and risk assessment. Originated and created post market surveillance plans for over 30 product families and conducted the first post market safety surveillance team review at the site. Led a cross divisional and functional quality team to develop a new computerized harmonized MDR compliant Post Market Surveillance report and system for use with PSURs, CERs, complaint management and health authority reporting. This system was used by over employees, Led and coordinated post market surveillance requirements for clinical evaluation reports, design dossiers, technical files, and risk and remediation activities within the biomaterials division. Modified the post market safety surveillance policy, standard, plan and report templates to ensure consistency between all DePuy Synthes divisions, improve the process and to address best practices. Modified supplier quality agreements to determine legal manufacturers, complaint and post market requirements between supplier and DePuy Synthes Completed a rotational assignment in Escalations. Responsible for conducting investigations into possible recall actions and other escalations. Involved in final decisions and made sure preventative and corrective actions were done.

Education

• Rutgers School of Engineering

  Bachelors of Science , Materials Engineering (Ceramics)

• Fox School of Business at Temple University

  MBA, General and Strategic Management

  1989 — 1992

• Rutgers University–New Brunswick

  Bachelor of Science - BS, Materials Engineering, ceramic engineering

• Rutgers University

  BS, Ceramic engineering

  1984 — 1988

Skills

• Process Engineering
• Change Control
• Quality Control
• Gmp
• Injection Molding
• Process Improvement
• Medical Devices
• Capa
• Root Cause Analysis
• Quality Assurance
• Lean Manufacturing
• Quality Engineering
• Process Validation
• Iso
• Business Process Improvement
• Fda
• 21 Cfr Part 11
• Continuous Improvement
• 21 Cfr
• Verification and Validation (V&V)
• Dmaic
• Manufacturing Engineering
• Supplier Quality
• Iso 14971
• Risk Management
• Fmea
• U.s. Food and Drug Administration (Fda)
• R&D
• Iso 13485
• Auditing
• Six Sigma
• Quality System
• V&V
• Quality Auditing
• Minitab
• Spc
• Biomedical Engineering
• Design Control
• Cqa
• Quality Management